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New cocktail targets Hard-to-Treat stomach cancer

NCT ID NCT05632939

Disease control Sponsor: AskGene Pharma, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial is testing a new drug called ASKB589, which targets a protein (CLDN18.2) found on some stomach cancer cells. It is given together with standard chemotherapy and an immunotherapy drug. The study includes 62 people with advanced stomach or gastroesophageal junction cancer that cannot be surgically removed. The main goals are to check safety, find the best dose, and see if the combination shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ASKB589 (a monoclonal antibody targeting CLDN18.2) combined with chemotherapy (oxaliplatin and capecitabine) and an immunotherapy (sintilimab or tislelizumab)
What this could lead to
If it works, this combination could offer a new first-line treatment option for people with advanced gastric cancer that cannot be removed by surgery.
What could go wrong
This is an early-phase trial with only 62 participants, so the main goal is safety and dosing—not yet proving the treatment works. Side effects from the drug combination could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

62 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic adenocarcinoma of the gastric and gastroesophageal junction currently ineligible for surgery and radical radiotherapy. 2. Investigators determined that the present situation of the patient justifies chemotherapy plus immunotherapy as first-line treatment. 3. Tumor tissue samples are CLDN18.2 positive detected by central laboratory 4. ECOG performance status 0-1. 5. The results of the laboratory tests must meet all criteria 6. Life expectancy of at least 3 months. Exclusion Criteria: 1. Known active central nervous system metastasis or suspected cancerous meningitis; 2. There are moderate to large amounts of abdominal and pleural fluid. 3. The presence of clinically uncontrollable third interspace fluid； 4. Patients with any other malignant tumors within the past 5 years. 5. Applicable to anti-HER-2 drug therapy； 6. Anti-CLDN18.2 antibody, anti-PD-1 antibody, or drug therapy at any time in the past； 7. Patients have received antitumor therapy during the first 4 weeks before study drug use; 8. Pregnant or lactating women; or women of childbearing age who have a positive blood pregnancy test during screening period; or women of childbearing age and their spouses who are unwilling to take effective contraceptive measures during the period of this clinical trial and within 6 months after the end of the clinical trial;

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal cancer gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer Gastroesophageal cancer (GC)

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100089, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.